A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.
NCT07389239 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-02-20
Summary
This phase I/IIA trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens.
Conditions
- Ovarian Cancer
- Advanced Malignant Solid Tumor
Interventions
- DRUG
-
Decitabine
Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6
- DRUG
-
Cyclophosphamide Conditioning
Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3
- BIOLOGICAL
-
NY-ESO-1 TCR/ dnTGFβRII
The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.
- DRUG
-
Aldesleukin
Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Daniel Olson · University of Chicago
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-23
- Primary Completion
- 2031-12-10
- Completion
- 2031-12-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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